FDA Expands Approval of Susvimo to Treat Diabetic Retinopathy

The FDA has approved Genentech’s Susvimo (ranibizumab) to treat patients with diabetic retinopathy (DR). This is the third FDA-approved indication for Susvimo, which is also approved for treating wet age-related macular degeneration and diabetic macular edema.

Diabetic retinopathy affects almost 10 million people in the United States. It can lead to diabetic macular edema, which is a leading cause of vision loss. Diabetic retinopathy is characterized by microvascular damage to the blood vessels in the retina, often caused by poor blood sugar control in people with diabetes.

Susvimo provides continuous delivery of a customized formulation of ranibizumab through a refillable ocular implant. The Port Delivery Platform is surgically inserted into the eye during a one-time, outpatient procedure. Genentech also markets Lucentis, a ranibizumab that is administered through a direct injection into the eye.

Levi Garraway, M.D., Ph.D.

“Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections,” Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said in a news release.

The approval for treating patients with diabetic retinopathy was based on positive one-year results from the phase 3 Pavilion study in patients with just one refill every nine months. Patients saw a reduction in the severity of eye damage caused by diabetes compared with those under monthly clinical observation who were treated with anti-VEGF injections. Additionally, none of the participants receiving Susvimo required supplemental treatment at one year.

The Pavilion trial, published March 6, 2025, in JAMA Ophthalmology, enrolled 174 people with diabetic retinopathy without center-involved diabetic macular edema who received Susvimo that was refilled at nine months. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52.

Adverse events include cataract, vitreous hemorrhage, a fluid-filled blister on the surface of the eye called a bleb, conjunctival retraction, conjunctival erosion and retinal detachment.

“This approach may help prevent vision-threatening complications by providing sustained anti-VEGF therapy, particularly in cases where lapses in care or delayed monitoring might otherwise lead to substantial vision loss before treatment is initiated,” researchers wrote in the JAMA Ophthalmology paper.

The list price of the Susvimo implant is $950, and a Susvimo refill costs $8,000. Genentech offers a $0 copay assistance program for the medication portion for patients with commercial insurance, with a limit of $15,000 a year. The company also provides copay assistance for administration costs with a limit of $1,000 a year. The terms say that this assistance is for the benefit of patients, and Genentech may adjust or exclude assistance if plans adjust cost-sharing programs or exclude the assistance from deductible or out-of-pocket limitations.

A Genentech spokesperson said Susvimo is covered by 95% of payers, including those on Medicare.

The FDA had originally approved Genentech’s Susvimo in October 2021. In October 2022, however, Genentech recalled the ocular implant, insertion tool, and initial fill kit in the United States after test results showed some implants, after repeated puncturing with a needle, did not perform to standards. The company reintroduced Susvimo after the FDA approved changes to the ocular implant and refill needle in July 2024.